Eye conditions tend to be linked to age, genetics, environment, tobacco abuse and diet. Most common eye conditions affecting the global population are age-related macular-degeneration (AMD), cataracts and xerophthalmia, the latter of which is caused by a deficiency of vitamin A, and which is a common cause of childhood blindness.
According to estimates by the World Health Organisation (WHO), more than two hundred and sixty million people around the world are affected by visual impairment, excluding blindness. Macular degeneration is more prevalent among senior adults and accounts for 7% of age-related conditions in people over the age of 50 years. According to a study published in the Indian Journal of Medical Sciences in 2007, the incidence of eye disease has been found to compound in humans at a mean age of 43.9 years.
The nutritional market for eye health products is dominated by dietary supplements, which comprised just over 66% of the market in the year 2007, according to a report by Frost & Sullivan analysts. Euromonitor estimates that eye health products account for 1% of total sales of the whole vitamins and dietary supplements market.
The market for eye health products in the USA is by far the most developed market, which is driven mainly by a greater acceptance and higher level of awareness of dietary supplements. Frost & Sullivan has estimated the US eye health ingredients market to be worth $138 (USD) million in the year 2008, with a compound annual growth rate (CAGR) of 5.3% from the year 2008 to the year 2015. The European market was valued at $43.4 (USD) million in the year 2007 with a CAGR of 10.5% from the year 2007 to the year 2014; such results are published at the following Internet website: see the website for nutraingredients.com/Product-Categories/Antioxidants-carotenoids/Unravelling-the-market-for-eye-health
Age-related macular degeneration (AMD) is a leading cause of a loss of adult vision amongst citizens in developed countries. AMD accounts for more than 50% of blindness amongst citizens in the United States of America (USA). More than 1.8 million citizens in the USA are affected by AMD. Moreover, it is expected that there will be an increase of 50% by the year 2030 in a total number of citizens in the USA affected by AMD as reported by Huang et al., 2008: National Eye Institute, “Vision problems in the US 2006” see the website for [nei.nih.gov/eyedata].
Based on major clinical studies, particularly a recent AREDS1 study, a known nutritional supplement formulation has been developed that is now used as a standard of care in certain cases of dry AMD. The known formulation, namely AREDS1 formulation, is used daily to deliver the following nutrients:
Vitamin C500 mgVitamin E400 International Units (IU) (268 mg)Beta-carotene15 mgZinc80 mg (in the form of Zinc Oxide)Copper2 mg (in the form of Cupric Oxide)
Several variations of the AREDS1 formulation from different suppliers are now available in the market for AMD patients and/or for healthy individuals as eye health nutritional supplement. These formulations are developed based on the results of the AREDS1 study and the cumulative clinical evidence about health benefits of other anti-oxidative nutrients, omega-3 fatty acids and herbal extracts.
Vision loss in sufferers with AMD is attributable to a death of photoreceptors in a central region of a human retina. An early stage of pathogenesis giving rise to AMD is associated with degeneration of retinal pigment epithelial (APR) cells, which is responsible for degradation of photoreceptor outer segments that have been shed. Such a mechanism for vision loss has been reported by Sheu et al., 2010 (Sheu S J, Lui N C, Chen J L, “Resveratrol protects human retinal pigment epithelial cells from acrolein-induced damage”, J. Ocul Pharmacol The 26(3): pp 231-236). Moreover, risk factors affecting development of AMD include an age greater than 50 years, Caucasian race, nutrition, smoking, cardiovascular disease, genetics, and sunlight exposure as reported in aforementioned Sheu et al., and also Thornton et al., 2005.
An average age of the population of the USA is increasing and therefore a total number of USA citizens with major eye disease is also correspondingly increasing. Although vision loss is becoming a major public health problem, contemporary therapy options for AMD are presently limited, and therefore, preventative interventions are needed to reduce a burden to society represented by vision loss as reported by Huang et al., 2008 (Huang L L, Coleman H R, Kim J, de Monasterio F, Wong W T, Schleicher R L, Ferris F L 3rd, Chew E Y (2008), “Oral supplementation of lutein/zeaxanthin an omega-3 long chain polyunsaturated fatty acids in persons aged 60 years or older, with or without AMD”, Invest Ophthalmol Vis Sci 49(9): pp. 3864-3869).
Nutritional supplements are contemporarily being used to an increasing extent for improving health and delaying age-related chronic diseases as reported by Marainin et al., 2009 (Maraini G, Williams S L, Sperduto R D, Ferris F L, Milton R C, Clemons T E, Rosmini F, Ferrigno L, 2009, “Effects of multivitamin/mineral supplementation on plasma levels of nutrients”, Report No. 4 of the Italian-American clinical trial of nutritional supplemented and age-related cataract, Ann 1st Super Sanita 45(2), pp. 119-127), by Joseph et al., 2009 (Joseph J, Cole G, Head E, Ingram D, 2009, “Nutrition, brain aging, and neurodegeneration”, J Neurosci 29(41), pp. 12795-12801), by Jones, 2007 (Jones A A, 2007, “Age related macular degeneration—should your patients be taking additional supplements?”, Aust Fam Physician 36(12), pp. 1026-1028) and by Cangemi 2007. Use of nutritional supplements has given a hope for development of new remedies and therapies for ameliorating AMD and to decelerate its progress as a function of adult age, and for reducing risk of vision loss.
In a Chinese patent application no. CN101062339A (20071031), there is described a composition including saffron and stilbene. Stilbene pertains to a specific chemical class of compounds which have in common a core diarylethene chemical moiety; the class includes a wide range of chemical entities. There is further described that Polygonum multiforum is a plant source of stilbene. More particularly, Polygonum multiforum is a source of 2,3,5,4′-tetrahydroxystilbene 2-O-β-D-glucopyranoside, namely stilbene glycoside. However, this combination does not show functional benefits provided by the present invention.
In a Chinese patent application no. CN101597554A, there is described an improvement of thick wine brewing technique in respect of foodstuffs, namely for preparing a restorative beverage, wherein saffron is employed merely as a colouring agent. Indeed, mixtures of fruits and spices have been used for centuries in the Middle East, without scientific and mechanism-based knowledge of any medicinal benefits arising therefrom.
Thus, from the foregoing, it will be appreciated that AMD is a major debilitating contemporary problem for millions of people around the World. A satisfactory solution has hitherto not been provided for the most prevalent form of the disease, known as dry AMD, which accounts for more than 90% of AMD cases, despite considerable research effort being devoted to try to find a solution.